BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 49

    MDR report key: 2915038 · Received January 15, 2013

    Report

    Report Number
    1818910-2013-00247
    Event Type
    Injury
    Date Received
    January 15, 2013
    Report Date
    April 25, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED: AGE, WEIGHT, BRAND NAME, DEVICE PRODUCT CODE, CATALOG #/LOT #, EXPLANT DATE, DATE REC'D BY MFR, PMA/510(K) #, MANUFACTURE DATE. UPDATE 04/25/2013 - SALES REP REPORTED REVISION OF LEFT HIP DUE TO PAIN. PART/LOT INFORMATION RECEIVED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    UPDATE 04/25/2013 - SALES REP REPORTED REVISION OF LEFT HIP DUE TO PAIN. PART/LOT INFORMATION RECEIVED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Description of Event or Problem · 1

    LITIGATION ALLEGED THE PATIENT HAS SUFFERED UNSPECIFIED INJURIES DUE TO THE DEFECTIVE IMPLANTED ASR HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21663 ASR UNI FEMORAL IMPL SIZE 49 FEMORAL HEAD HIP IMPLANT KWA DEPUY INTERNATIONAL 2748831

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other